Sleek ‘Lab in a Needle’ Is an All-in-One Device That Detects Liver Toxicity in Minutes during a Study, Showing Potential to Supplant Some Medical Laboratory Tests

Researchers’ prototype uses lab-on-a-chip technology and seems to do it all, from collection and analysis to results in minutes and in the palm of your hand Here’s a diagnostic workhorse that can also easily slip inside the pocket of a doctor’s white coat. The slim device, created and reported by researchers, integrates a clinical laboratory’s workflow from collecting samples to analyzing them and reporting results in minutes. The device is dubbed “lab in a needle” by researchers at Houston...

Enforcement of FDA’s Unique Device Identification Law Begins as Hospitals, ASCs, and Nursing Homes Must Now Report Adverse Patient Events from High-Risk Medical Devices

Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device. The primary goal of the new regulation is to have specified providers...

FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs. UDIs also will apply to certain combinations of products that contain devices...

New iPhone App Allows Consumers to Test Their Urine on the Go for as Many as 25 Different Diseases

Pathologists and clinical laboratory managers may want to learn more about the UCheck mobile app developed by Biosense Technologies   Developers of a new iPhone application claim their app can analyze a urine specimen for up to 25 different diseases. This mobile app is a deliberate attempt to give consumers the ability to perform diagnostic tests that would normally be run in a full-scale clinical laboratory. Pathologists and clinical biochemists will want to visit the website of Biosense...

FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers. You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally...